Clinical Project Manager

vor 1 Woche

Zurich, Schweiz SIVA Health AG Vollzeit

SIVA Health AG is a digital health startup company in the field of sound-based respiratory diagnostics, located in Zurich, Switzerland. Through collaboration with global corporate partners, clinics, and researchers, we at SIVA Health have developed a novel device to continuously measure cough (24/7). This innovation is currently being used in global clinical multi-center studies.

Tasks
- Lead and manage the study operations, ensuring effective communication and coordination with internal team members and external collaborators (clinical research organizations, pharmaceutical companies, investigators).
- Drive product understanding, conduct product testing, develop procedures and optimize processes.
- Foster and maintain strong relationships with clients in the pharmaceutical industry, healthcare providers, CROs, and Key Opinion Leaders.
- Lead the ongoing client support to ensure satisfaction and product adoption.
- Understand regulatory frameworks for various jurisdictions (e.g., EU (MDR), USA (FDA)), review relevant documentation and ensure compliance.
- Lead and execute the regulatory strategy, in particular for FDA submission.
- Participate in Post-Market-Surveillance (PMS) activities and maintain up-to-date knowledge of regulatory requirements.
- Stay up to date with the relevant scientific fields, conduct literature reviews and write scientific articles.
- Lead the development of clinical studies and usability tests needed for regulatory approvals.

**Requirements**:

- PhD in a related field (e.g., Life Sciences) or a Bachelor’s degree in a related field (e.g., Life Sciences, Clinical Research, Regulatory Affairs) with 3-5 years of relevant work experience.
- Excellent organizational and project management skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Proficient in writing and reviewing scientific and regulatory documents.
- Ability to work collaboratively with cross-functional teams.
- Strong interpersonal skills with the ability to build rapport and communicate effectively with clients.
- Strong analytical and problem-solving skills.
- Fluent in English. Fluency in German or French is a plus.

Please note that we only accept applicants with an existing and valid residence and work permit for Switzerland.

**Benefits**:

- Possibility to contribute to an innovation that addresses an unmet medical need.
- Being part of a small MedTech in a forward-driven team.
- Working with a high degree of autonomy and responsibility.
- Excellent coffee in our Zurich Wiedikon office
- Career growth and development opportunities.

Are you interested in helping us explore new areas in the field of respiratory diagnostics? If so,we look forward to talking to you soon The sooner you can start, the better

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